Manufacturer’s Declaration in relation to Regulation (EU) 2023/607

MedTech Europe* is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to Regulation (EU) 2023/607 and:

• The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC or Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or
• The compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

Any medical device manufacturer may freely use this template to make their own declaration of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares their compliance with the applicable conditions is disclosed by the manufacturer in the completed form.

The template consists of two parts:

• A text part with selectable portions of text as they apply and
• a schedule which lists the devices which the manufacturer intends to cover in its Declaration.

Please note that for legacy In Vitro Diagnostic medical devices, a template Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 can be found on MedTech Europe’s website here.

* This template was jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology and MedTech Europe. The manufacturer or authorised representative takes their own responsibility when using or adapting the form.  MedTech Europe does not take any responsibility for the content of the template or its terms and its use by the manufacturer or their authorised representative.

Please find the template below.